A Study on the Efficacy and Safety of Gabapentin in the Treatment of Patients With Painful Diabetic Neuropathy

Overview[ - collapse ][ - ]

Purpose The purpose of this study was to evaluate the efficacy, safety, and tolerability of gabapentin for the treatment of patients with painful diabetic neuropathy. The quality of life of all treated patients was also assessed.
ConditionDiabetic Neuropathies
InterventionDrug: gabapentin
PhasePhase 4
SponsorPfizer
Responsible PartyPfizer
ClinicalTrials.gov IdentifierNCT00644748
First ReceivedMarch 25, 2008
Last UpdatedOctober 9, 2008
Last verifiedOctober 2008

Tracking Information[ + expand ][ + ]

First Received DateMarch 25, 2008
Last Updated DateOctober 9, 2008
Start DateMay 2003
Estimated Primary Completion DateAugust 2004
Current Primary Outcome MeasuresChange from baseline Mean Pain Score [Time Frame: Endpoint] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Change from baseline Mean Pain Score [Time Frame: Weekly] [Designated as safety issue: No]
  • Proportion of responding patients [Time Frame: Endpoint] [Designated as safety issue: No]
  • Change from baseline Mean Pain Interference with Sleep Score [Time Frame: Weekly and Endpoint] [Designated as safety issue: No]
  • Change from baseline in the 5 sub-scores of the McGill Reduced Pain Questionnaire: the sensory score, the affective score, the total score for pain descriptors, a visual analogue scale, and a scale of Present Pain Intensity [Time Frame: Endpoint] [Designated as safety issue: No]
  • Global Change Impression from the Patient's Point of View [Time Frame: Endpoint] [Designated as safety issue: No]
  • Change from baseline in quality of life [Time Frame: Endpoint] [Designated as safety issue: No]
  • Global Change Impression from the Physician's Point of View [Time Frame: Endpoint] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleA Study on the Efficacy and Safety of Gabapentin in the Treatment of Patients With Painful Diabetic Neuropathy
Official TitleAn Open, Multicenter Study on the Efficacy, Safety and Tolerability of Gabapentin, Titrated for Reaching an Effect for the Treatment of the Painful Diabetic Neuropathy
Brief Summary
The purpose of this study was to evaluate the efficacy, safety, and tolerability of
gabapentin for the treatment of patients with painful diabetic neuropathy. The quality of
life of all treated patients was also assessed.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionDiabetic Neuropathies
InterventionDrug: gabapentin
Gabapentin oral capsules:
Week 0: Day 1: 300 mg; Day 2: 600 mg (2 doses of 300 mg); Day 3: 900 mg (3 doses of 300 mg), maintained until the end of the week; After this point, the total daily dose was divided in 3 equal doses. Week 1: Day 1: 1200 mg; Day 2 to 7: 1800 mg Week 2: Day 1: 2100 mg; Day 2 to 7: 2400 mg Week 3: Day 1: 2700 mg; Day 2 to 7: 3600 mg Weeks 4 to 11: 3600 mg
Study Arm (s)Experimental: Gabapentin group

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment95
Estimated Completion DateAugust 2004
Estimated Primary Completion DateNot Provided
Eligibility Criteria
Inclusion Criteria:

- Patients with stable Diabetes Mellitus 1 or 2

- Clinical diagnosis of distal symmetric polyneuropathy with a minimum duration of 8
weeks

- No clinically significant motor deficits

- Pain described according to at least one of the following clinical manifestations:
burning, cramps or twinges, thermal or mechanical alodinea

Exclusion Criteria:

- Treatment with any medication that may interfere with the assessment of gabapentin
during the study or within 7 days of the adminstration of gabapentin

- Specific systemic diseases or other medical conditions that would interfere with the
assessment of gabapentin therapeutic response or safety
GenderBoth
Ages51 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesBrazil

Administrative Information[ + expand ][ + ]

NCT Number NCT00644748
Other Study ID NumbersA9451004
Has Data Monitoring CommitteeNo
Information Provided ByPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators Study Director: Pfizer CT.gov Call Center Pfizer
Verification DateOctober 2008

Locations[ + expand ][ + ]

Pfizer Investigational Site
Fortaleza, Ceara, Brazil, 60120-021
Pfizer Investigational Site
Taguatinga, DF, Brazil, 72119-900
Pfizer Investigational Site
Belo Horizonte, MG, Brazil, 30150-221
Pfizer Investigational Site
Curitiba, Parana, Brazil, 80060-150
Pfizer Investigational Site
Recife, Pernambuco, Brazil, 52051-380
Pfizer Investigational Site
Rio de Janeiro, RJ, Brazil, 20211-340
Pfizer Investigational Site
Porto Alegre, RS, Brazil
Pfizer Investigational Site
Unknown, Sao Paulo, Brazil
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 01246-903
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 04020-041